Intestinal sleeve

ABSTRACT

A gastrointestinal system includes a bracelet type anchor constructed and arranged to reside in a body cavity, a gastrointestinal sleeve configured to expand under a load and contract when the load is removed and a string connecting a bracelet type anchor with the sleeve. Pulling the string transforms the bracelet type anchor from a flexible mode into a rigid state.

TECHNOLOGY FIELD

The present sleeve is related to sleeves for insertion into animal orhuman intestines.

BACKGROUND

Use of gastrointestinal implant devices and in particular bariatricdevices is believed to be an effective treatment for obesity as well asfor type 2 diabetes and a number of other obesity-related conditions.The bariatric devices are adapted to be inserted intraorally into thestomach and extend from the stomach into the intestines. All foodexiting the stomach is funneled through the implant device.

A gastrointestinal implant device includes an unsupported flexible,collapsible sleeve and an anchor. The anchor is usually coupled to aproximal to the stomach portion of the sleeve. The flexible sleeve isopen at both ends, and adapted to extend into the small intestine and inparticular to duodenum to limit absorption of nutrients in the smallintestine and duodenum. The anchor is adapted to secure and retain thesleeve within the duodenum.

Small intestine length being in contact with the digested food or chimedetermines the caloric absorptive capacity. The gastrointestinal implantdevice lining the intestine limits the small bowel length being incontact with the digested food. It receives from the stomach thedigested food and delivers it 30-100 cm down the intestines. This delaysthe breakdown and subsequent digestion of food.

Different gastrointestinal devices including intestinal sleeves aredescribed in several United States patents, including the following U.S.Pat. No. 8,855,770 to Gross et al.; U.S. Pat. No. 8,888,732 to Raven etal.; U.S. Pat. No. 8,956,380 to Dominguez et al.; U.S. Pat. No.9,011,365 to Connor; U.S. Pat. No. 9,173,734 to Vargas; U.S. Pat. No.9,289,580 to Coleman et al.; U.S. Pat. No. 9,463,107 to Babkes et al.;U.S. Pat. No. 9,504,591 to Burnett et al.; U.S. Pat. No. 9,681,974 toDominguez et al.; U.S. Pat. No. 9,717,584 to Culley et al.; and UnitedStates Patent Application Publications 20030114803 to Lerner;20120232459 to Dann et al.; 20140316265 to Levin et al. and 20170181877to Binmoeller.

SUMMARY

An intestinal sleeve including one or more sleeve segments. Each sleevesegment is a coaxial structure that includes an outer cylindrical walland an inner cylindrical wall and an elastic element disposed betweenthe outer cylindrical wall and an inner cylindrical wall. The outercylindrical wall and an inner cylindrical wall of the sleeve segment arefurrow-like surfaces. A resilient membrane made from silicone isdisposed between the sleeve segments and each resilient membraneincludes a central opening. Each sleeve segment is configured to extendits length according to load carried by the resilient membrane and whenthe load is removed contract each sleeve segment to initial length.

According to another aspect of an embodiment, a gastrointestinal systemincludes a bracelet type anchor residing in a body cavity, agastrointestinal sleeve configured to expand under a load and contractwhen the load is removed and a string connecting a bracelet type anchorwith the sleeve. Pulling the string transforms the bracelet type anchorfrom a flexible mode into a rigid state.

According to yet another aspect of an embodiment, a method extends alength of an intestinal sleeve such that the digested food entering thesleeve extends the length of the intestinal sleeve and extends thelining to a larger portion of the intestine. This reduces absorption ofthe digested food nutrients by the intestine.

LIST OF FIGURES AND THEIR BRIEF DESCRIPTION

FIG. 1 is an example of a prior art intestinal sleeve;

FIG. 2 is an example of another prior art intestinal sleeve;

FIG. 3 is an example of an additional prior art intestinal sleeve;

FIG. 4 is an example of a present intestinal sleeve;

FIG. 5 is an example of a segment of the present sleeve;

FIG. 6 is another example of a segment of the present sleeve;

FIG. 7 is an example of the present sleeve inserted into an intestine;

FIG. 8 is an example demonstrating how the present sleeve inserted intoan intestine expands under a load; and.

FIG. 9 is an example of a gastrointestinal system including animplantable bracelet type anchor and the disclosed above sleeve.

DESCRIPTION

Gastrointestinal operations usually combine insertion of a restrictivegastric element anchored in a stomach and a certain extended tubularelement residing in the intestines. The food is routed into theintestines and passes through the tubular element or sleeve. The sleeveis lining the internal walls of the intestines and causes certain effectof nutrients malabsorption. Generally, the sleeves are of constantlength, although as disclosed in U.S. Pat. No. 7,682,330 the sleevelength could be variable and can range from about one foot to about fivefeet, when measured from the anchor. The patent does not disclose themeans by which extension of sleeve length is achieved.

U.S. Pat. No. 9,289,580 discloses that the length of a sleeve can beadjusted in a variety of ways, for example, by rotating a rod disposedbetween the proximal and distal ends of the anastomotic device.

It is known that some suppliers of sleeves produce about three-foursizes adapted to physical parameters of the treated object. It is knownthat the sleeve length could be different for diabetes and weightreduction. However, a large number of obese people suffer also fromdiabetes.

It would be desirable to have a variable length sleeve that in course ofits use could line/cover a variable length segment of the intestines.

Insertion of such sleeve would be a less invasive alternative to thebariatric surgery. The “active sleeve” that extends its length accordingto the amount of food ingested could improve both weight loss processand used for diabetes treatment.

FIGS. 1 through 3 illustrate different designs of currently manufacturedintestinal sleeves. FIG. 1 is an example of a regular intestinal sleeve.Walls 104 of sleeve 100 are usually made from Tetrafluoroethylene orPolytetrafluoroethylene (PTFE) known under trade name Teflon®. Walls 104could have a thickness of 20 to 50 micron. Sleeve 100 could be made of adesired length L, for example 50 or 60 cm. Teflon® is a materialnon-permeable by the chime and other products of stomach activity.

Sleeve 200 includes in one of its ends, typically the end proximal tostomach a longitudinal spring 204 configured to fix the sleeve to theintestine. The spring may reside in the stomach or be supported by thepylorus.

Sleeve 300 includes in one of its ends, typically the end proximal tostomach, a conical funnel like expansion 304 configured to fix thesleeve to the intestine. The funnel like expansion could reside in thestomach or be supported by the pylorus.

Generally, sleeves 100-300 in addition to their own supports are linkedto supports or anchors residing in the stomach.

FIG. 4 is an example of a present intestinal sleeve 400. Intestinalsleeve 400 includes at least one sleeve segment 404 and usually aplurality of segments 404. The number of sleeve segments 404 sets theinitial or original length of sleeve 400, although a single sleevesegment could be long enough and have a length similar to the existingsleeves length. Each sleeve segment 404 has a coaxial structureincluding an outer cylindrical wall 408 and an inner cylindrical wall412. An elastic element 416 is disposed between walls 408 and 412 ofeach of the segments. Elastic element 416 could have a cylindrical shapeor represent a number of separate elastic strips. The length of theelastic element 416 in a free, not tensioned state is generally shorterthan the length of walls 408 and 412 of each of segments 404. Thiscontracts the outer cylindrical wall 408 and inner cylindrical wall 412such that their surface becomes a furrow-like surface forming on walls408 and 412 structure of alternate protruding and recessing sectionscausing each segment 404 to look-like a bellow device, although thefurrows shown as equally spaced, there spacing could be irregular.Bellows are devices the walls of which expand and contract in responseto changes in the applied force. The applied force changes the length ofthe bellow.

Each sleeve segment 408 further comprises a first proximal to thestomach end 420, a second end 424, walls 408 and 412 and elastic element416 that extends axially there-between. Each end 420 and 424 of elasticelement 416 is fixed to a respective resilient membrane 432. Wall 412defines an interior chamber 428 that communicates with animal or humanstomach. A resilient membrane 432 is attached to first 420 and second424 ends. Resilient membrane 432 is disposed between segments 404 ofintestinal sleeve 400 so as to divide the segments. Each resilientmembrane 432 includes an opening 436 illustrated as a central opening,although opening 436 could be shifted from the center of resilientmembrane 432. Resilient membrane 432 is typically made from silicone andhas a thickness of 1.0 mm to 2.0 mm. The stiffness of resilient membranecould be regulated by using different thickness and type of silicone. Insome examples resilient membrane 432 could be configured to bend under aload. Resilient membrane is configured to restore its initial position,when the load is removed. In some examples resilient membrane 432 couldbe made from the same material the sleeve is made and be integral withthe sleeve.

Resilient membrane 432 receives load 440 (digested food or chime) fromthe stomach. As the load 440 is received and fills-in interior chamber428, the force applied by load 440 to resilient membrane 432 as shown inFIG. 5, extends the lengths of segment 404 of intestinal sleeve 400 on avalue of ΔL according to the load 440.

Each sleeve segment 408 extends under a load at least 5%. In someexamples segment 408 extends 20% or even 50%. Accordingly, the length ofintestinal sleeve 400 extends on the sum of extensions of each segment408. When load 440 is removed, elastic element 416 is configured tocontract each segment 408 to its' initial or original length.

FIG. 7 is an example of the present sleeve inserted into an intestine.The figure schematically illustrates stomach 500, pylorus 504 and ananchor such as longitudinal spring 508 holding or fixing in placeinserted intraorally intestinal sleeve 400. Longitudinal spring 508holds or fixes sleeve 400 at the entrance to the intestines. Accordingto the present disclosure the insertion (placement) of a non-permeableintestinal sleeve 400 lining a segment of small intestine 512 leads toreduced nutrient absorption and helps in losing weight.

FIG. 8 is an example demonstrating how the present sleeve 408 insertedinto an intestine extends its length under a load and increases thesegment of small intestine 512 covered by the sleeve. The extendedsleeve covers a longer segment of the small intestine walls and leads toreduced nutrient absorption helping to lose weight.

It is known that one of the obesity treatments includes insertion of agastrointestinal system including an impermeable sleeve made fromTeflon. The sleeve is anchored in the small intestine by a radiallycompressible nitinol wave anchor. The wave anchor anchors the sleeve andrestrains the sleeve movement within the intestines.

The sleeve extends about 40-60 cm into the small intestine. This createsa mechanical barrier that allows food to bypass the duodenum andproximal jejunum without mixing with pancreas secretions. In addition tothe spring anchors 508 restraining the movement from intestines into thestomach, the sleeve is anchored by an anchor residing in the stomach andrestraining the movement of the sleeve down the intestines. U.S.Provisional Patent Application No. 62/613,065 to the same inventor andassignee and incorporated herein in its entirety discloses a bracelettype anchor that when inserted in the stomach 500 is restraining themovement of the sleeve down the intestines.

FIG. 9 is an example of a gastrointestinal system including animplantable bracelet type anchor and the disclosed above sleeve. Theimplantable bracelet type anchor or device 900 shown in the rigid stateand fixed in body cavity which could be a stomach 500, when device 900is in rigid state device 900 movement in body cavity 500 is constrained.String 904 links device 900 to wave anchor 508 and sleeve 408. String904 is also used to lock the shape of bracelet type anchor 900. Bracelettype anchor 900 is inserted and removed from stomach 500 throughstandard intraoral procedures in a flexible mode. Pulling of string 904transforms bracelet type anchor from the flexible mode into a rigidstate.

A number of examples have been described. Nevertheless, it will beunderstood that various modifications may be made without departing fromthe spirit and scope of the method. Accordingly, other examples arewithin the scope of the following claims.

What is claimed is:
 1. A gastrointestinal system comprising a bracelettype anchor constructed and arranged to reside in a body cavity; agastrointestinal sleeve configured to expand under a load and contractwhen the load is removed; and a string connecting the bracelet typeanchor with the sleeve; and wherein pulling the string transforms thebracelet type anchor from a flexible mode into a rigid state.
 2. Thesystem according to claim 1, wherein the load is digested food.
 3. Thesystem according to claim 1, wherein the gastrointestinal sleeveincludes in an end proximal to stomach, a longitudinal spring configuredto fix the sleeve to the intestine.
 4. The system according to claim 1,wherein the gastrointestinal sleeve includes in an end proximal tostomach, a conical funnel-like expansion portion configured to fix thesleeve to the intestine.
 5. The system according to claim 1, wherein thegastrointestinal sleeve includes a plurality of sleeve segments andwherein each segment has a coaxial structure including an outercylindrical wall and an inner cylindrical wall and an elastic elementdisposed between the walls of each of the segments.
 6. The systemaccording to claim 1, wherein the gastrointestinal sleeve includes aplurality of sleeve segments and includes a resilient membrane disposedbetween the sleeve segments and wherein the resilient membrane includesan opening shifted from a center of the resilient membrane.
 7. Thesystem according to claim 1, wherein the bracelet type anchor isconstructed and arranged such that when in the rigid state, itconstrains movement thereof when in the body cavity.
 8. The systemaccording to claim 1, wherein the string is constructed and arranged tolock a shape of the bracelet type anchor.